WASHINGTON -- The FDA has approved the first drug for treatment of HIV patients with lipodystrophy, a condition associated with antiretroviral therapy.

WASHINGTON -- The FDA has approved the first drug for treatment of HIV patients with lipodystrophy, a condition associated with antiretroviral therapy.

The drug, tesamorelin (Egrifta) is a growth hormone releasing factor drug, which is administered by injection once daily.

The FDA decision was based on findings from two clinical trials involving 816 HIV-infected adult men and women with lipodystrophy and excess abdominal fat. Of these, 543 patients received tesamorelin during a 26-week, placebo-controlled period. In both studies, patients treated with tesamorelin experienced greater reductions in abdominal fat as measured by CT scan, compared with patients receiving another injectable solution (placebo).

Some patients reported improved self image.

The drug was not assessed for cardiovascular safety nor was it assessed as a means of improving compliance with antiretroviral therapy.

The most common toxicities were arthralgia, erythema, pruritus, gastrointestinal pain, edema, and myalgia. Worsening blood sugar control occurred more often in patients treated with tesamorelin than with placebo.

The drug was developed by Montreal-based Theratechnologies and marketed in the U.S. by EMD Serono, of Rockland, Mass.

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